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Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study

ConditionHER2 + Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorLiu Shu

About this trial

This is a multicenter, open-label, dose-finding trial using a backfill Bayesian optimal interval (BF-BOIN) design to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for paclitaxel oral solution combined with anti-HER2 treatment. Eligible HER2-positive breast cancer patients receive 6 cycles of neoadjuvant THP regimen(paclitaxel oral solution + trastuzumab+pertuzumab) and are enrolled in three cohorts at oral paclitaxel dose levels 1-3 (125, 150, 175 mg/m²).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female, aged 18 to 70 years.

Histologically confirmed invasive breast cancer by core needle biopsy; clinical stage T1c-4, N0-3, M0 per the AJCC 8th edition breast cancer staging system (T1cN0M0 excluded).

HER2-positive status defined as IHC 3+ or IHC 2+ with FISH amplification.

Left ventricular ejection fraction (LVEF) ≥ 50%.

Disqualifiers

History of prior invasive breast cancer.

Bilateral breast cancer, or inflammatory breast cancer (e.g., erythema and/or skin involvement and/or pathological evidence of tumor cells in dermal lymphatics).

Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.

Prior systemic therapy for breast cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Paclitaxel oral solution plus Trastuzumab and Pertuzumab

    Combination product

    Eligible patients in three cohorts receive 6 neoadjuvant THP cycles: paclitaxel oral solution at 125/150/175 mg/m² BID (D1, D8, D15), and dual anti-HER2 therapy - trastuzumab (8→6 mg/kg IV or 600 mg SC) and pertuzumab (840→420 mg IV), both Q3W - or, alternatively, the pertuzumab/trastuzumab SC fixed-dose combination (Phesgo; loading 1200/600 mg \[15 mL\], maintenance 600/600 mg \[10 mL\]), Q3W; all for 6 cycles.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Dose-level 1 cohortExperimental treatment 1 intervention
Group B: Dose-level 2 cohortExperimental treatment 1 intervention
Group C: Dose-level 3 cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose(MTD)

The incidence of dose-limiting toxicitys and any AEs will be assessed. After the trial is completed, the MTD is determined with all the data based on isotonic regression by the shiny app "BF-BOIN" available at http://www.trialdesign.org.

Time frame
Up to 24 weeks.

Secondary outcomes

1

total Pathological Complete Response(tpCR)

It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).

Time frame
Up to six months.
2

Overall Response Rate(ORR)

Response Evaluation Criteria in Solid Tumors (RECIST)：Progressive Disease (PD); Partial Response (PR); Complete Response (CR); Stable Disease (SD) Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) partial response (PR) to treatment.

Time frame
Up to 24 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liu Shu

Lead sponsor

The Affiliated Hospital Of Guizhou Medical University

Sponsor institution

Source ClinicalTrials.gov
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